-
1.
Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials.
Moschonis, G, Siopis, G, Jung, J, Eweka, E, Willems, R, Kwasnicka, D, Asare, BY, Kodithuwakku, V, Verhaeghe, N, Vedanthan, R, et al
The Lancet. Digital health. 2023;(3):e125-e143
Abstract
BACKGROUND Digital health interventions have shown promising results for the management of type 2 diabetes, but a comparison of the effectiveness and implementation of the different modes is not currently available. Therefore, this study aimed to compare the effectiveness of SMS, smartphone application, and website-based interventions on improving glycaemia in adults with type 2 diabetes and report on their reach, uptake, and feasibility. METHODS In this systematic review and meta-analysis, we searched CINAHL, Cochrane Central, Embase, MEDLINE, and PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) that examined the effectiveness of digital health interventions in reducing glycated haemoglobin A1c (HbA1c) in adults with type 2 diabetes, published in English from Jan 1, 2009. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint assessed was the change in the mean (and 95% CI) plasma concentration of HbA1c at 3 months or more. Cochrane risk of bias 2 was used to assess risk of bias. Data on reach, uptake, and feasibility were summarised narratively and data on HbA1c reduction were synthesised in a meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation criteria was used to evaluate the level of evidence. The study was registered with PROSPERO, CRD42021247845. FINDINGS Of the 3236 records identified, 56 RCTs from 24 regions (n=11 486 participants), were included in the narrative synthesis, and 26 studies (n=4546 participants) in the meta-analysis. 20 studies used SMS as the primary mode of delivery of the digital health intervention, 25 used smartphone applications, and 11 implemented interventions via websites. Smartphone application interventions reported higher reach compared with SMS and website-based interventions, but website-based interventions reported higher uptake compared with SMS and smartphone application interventions. Effective interventions, in general, included people with greater severity of their condition at baseline (ie, higher HbA1c) and administration of a higher dose intensity of the intervention, such as more frequent use of smartphone applications. Overall, digital health intervention group participants had a -0·30 (95% CI -0·42 to -0·19) percentage point greater reduction in HbA1c, compared with control group participants. The difference in HbA1c reduction between groups was statistically significant when interventions were delivered through smartphone applications (-0·42% [-0·63 to -0·20]) and via SMS (-0·37% [-0·57 to -0·17]), but not when delivered via websites (-0·09% [-0·64 to 0·46]). Due to the considerable heterogeneity between included studies, the level of evidence was moderate overall. INTERPRETATION Smartphone application and SMS interventions, but not website-based interventions, were associated with better glycaemic control. However, the studies' heterogeneity should be recognised. Considering that both smartphone application and SMS interventions are effective for diabetes management, clinicians should consider factors such as reach, uptake, patient preference, and context of the intervention when deciding on the mode of delivery of the intervention. Nine in ten people worldwide own a feature phone and can receive SMS and four in five people have access to a smartphone, with numerous smartphone applications being available for diabetes management. Clinicians should familiarise themselves with this modality of programme delivery and encourage people with type 2 diabetes to use evidence-based applications for improving their self-management of diabetes. Future research needs to describe in detail the mediators and moderators of the effectiveness and implementation of SMS and smartphone application interventions, such as the optimal dose, frequency, timing, user interface, and communication mode to both further improve their effectiveness and to increase their reach, uptake, and feasibility. FUNDING EU's Horizon 2020 Research and Innovation Programme.
-
2.
Citizen Science to improve healthy and active living among adolescents in four European countries: a protocol of the cluster randomised controlled trial of the Science Engagement to Empower aDolescentS (SEEDS) project.
Wargers, A, Queral, J, Mölenberg, FJ, Tarro, L, Elphick, CM, Kalogerakou, E, Karagiannis, A, Llauradó, E, Manios, Y, Mavrogianni, C, et al
BMJ open. 2023;(5):e070169
Abstract
INTRODUCTION Improving healthy lifestyles of adolescents is challenging. Citizen Science is a way to engage them in the design and delivery of interventions, and may also increase their interest in science, technology, engineering and mathematics (STEM). The Science Engagement to Empower aDolescentS (SEEDS) project aims to use an equity-lens, and engage and empower boys and girls from deprived areas by designing and cocreating interventions to promote healthy lifestyles, and to seed interest in STEM. METHODS AND ANALYSIS SEEDS is a cluster randomised controlled trial in four countries (Greece, the Netherlands, Spain and the UK). Each country will recruit six to eight high schools from lower socioeconomic neighbourhoods. Adolescents aged 13-15 years are the target population. High schools will be randomised into intervention or control group. Each country will select 15 adolescents from intervention schools called ambassadors, who will be involved throughout the project.In each country, focus groups with ambassadors and stakeholders will focus on physical activity, snacking behaviour and STEM. The input from focus groups will be used to shape Makeathon events, cocreation events where adolescents and stakeholders will develop the interventions. The resultant intervention will be implemented in the intervention schools during 6 months. In total, we aim to recruit 720 adolescents who will complete questionnaires related to healthy lifestyles and STEM outcomes at baseline (November 2021) and after the 6 months (June 2022). ETHICS AND DISSEMINATION The four countries obtained approval from their corresponding Ethics Committees (Greece: Bioethics Committee of Harokopio University; the Netherlands: The Medical Research Ethics Committee of the Erasmus Medical Center; Spain: The Drug Research Ethics Committee of the Pere Virgili Health Research Institute; UK: Sport and Health Sciences Ethics Committee of the University of Exeter). Informed consent will be collected from adolescents and their parents in line with General Data Protection Regulation legislation. The findings will be disseminated by conference presentations, publications in scientific peer-reviewed journals and during (local) stakeholders and public events. Lessons learnt and the main results will also be used to provide policy recommendations. TRIAL REGISTRATION NUMBER NCT05002049.
-
3.
Longitudinal associations between diet quality, sedentary behaviours and physical activity and risk of overweight and obesity in preschool children: The ToyBox-study.
Miguel-Berges, ML, Mouratidou, T, Santaliestra-Pasias, A, Androutsos, O, Iotova, V, Galcheva, S, De Craemer, M, Cardon, G, Koletzko, B, Kulaga, Z, et al
Pediatric obesity. 2023;(10):e13068
Abstract
BACKGROUND Lifestyle behaviours related to diet and physical activity are associated with increased risk of obesity and evidence suggests that associations might be stronger when a synergetic effect is examined. OBJECTIVE To examine the cross-sectional and longitudinal associations between diet, screen time (ST) and step recommendations and risk of overweight and obesity in European preschoolers participating in the ToyBox-study. METHODS In this cluster-randomized clinical trial, 718 children (51.4% boys) from six European countries participated. Parents filled out questionnaires with information on socio-demographic status, step recommendations and ST. RESULTS Longitudinal results indicate that participants having a low Diet Quality Index (DQI), not meeting ST and step recommendations at T0 and T1 had higher odds of having overweight/obesity at T1 (odds ratio [OR] = 1.116; 95% confidence interval [CI] = 1.104-2.562) than those children having a high DQI and meeting ST and step recommendations at T0 and T1. Similarly, participants having a high DQI, but not meeting ST and step recommendations at T0 and T1 had increased odds of having overweight/obesity (OR = 2.515; 95% CI = 1.171-3.021). CONCLUSIONS The proportion of participants having a low DQI, not adhering to both step and ST recommendations was very high, and it was associated with a higher probability of having overweight and obesity.
-
4.
The Effect of Acute Pre-Workout Supplement Ingestion on Basketball-Specific Performance of Well-Trained Athletes.
Douligeris, A, Methenitis, S, Lazou, A, Panayiotou, G, Feidantsis, K, Voulgaridou, G, Manios, Y, Jamurtas, AZ, Giaginis, C, Papadopoulou, SK
Nutrients. 2023;(10)
Abstract
A pre-workout supplement's (PWS; 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g β-alanine, 6 g citrulline malate and 5 g branched chained amino acid (BCAA) per dose) acute effects on the alactic (jumping, sprinting, agility), lactic (Running-Based Anaerobic Sprint Test, RAST) and aerobic performance (Yo-Yo Intermittent Recovery Test Level 1, Yo-Yo IRL1 VO2max) of well-trained basketball players was investigated in this double-blind placebo-controlled study. Thirty players (age 18-31 years, height 166-195 cm, weight 70.2-116.7 kg, body fat 10.6-26.4%) were allocated to pre-workout (PWS, n = 15) or placebo (PL, n = 15) groups. Half of the participants in each group performed the evaluations without PWS or PL, while the rest consumed PWS or PL 30 min before the assessments (1st trial) and vice versa (2nd trial). Significant improvements in counter-movement jump (CMJ) (PWS: 4.3 ± 2.1%; PL: 1.2 ± 1.0%), agility (PWS: -2.9 ± 1.8%; PL: 1.8 ± 1.7%), RAST average (PWS: 18.3 ± 9.1%; PL: -2.2 ± 2.0%), minimum power (PWS: 13.7 ± 8.9%; PL: -7.5 ± 5.9%), and fatigue index (PWS: -25.0 ± 0.9%; PL: -4.6 ± 0.6%) were observed in the PWS group vs. the PL group (p < 0.05). No differences were found regarding sprinting, aerobic performance, and blood lactate concentrations. Thus, although players' alactic and lactic anaerobic performance could be improved, peak power, sprinting and aerobic performance are not.
-
5.
Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension: a systematic review and meta-analysis of randomised controlled trials.
Siopis, G, Moschonis, G, Eweka, E, Jung, J, Kwasnicka, D, Asare, BY, Kodithuwakku, V, Willems, R, Verhaeghe, N, Annemans, L, et al
The Lancet. Digital health. 2023;(3):e144-e159
Abstract
BACKGROUND Digital health interventions are effective for hypertension self-management, but a comparison of the effectiveness and implementation of the different modes of interventions is not currently available. This study aimed to compare the effectiveness of SMS, smartphone application, and website interventions on improving blood pressure in adults with hypertension, and to report on their reach, uptake, and feasibility. METHODS In this systematic review and meta-analysis we searched CINAHL Complete, Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid MEDLINE, and APA PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) published in English from Jan 1, 2009, that examined the effectiveness of digital health interventions on reducing blood pressure in adults with hypertension. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint was change in the mean of systolic blood pressure. Risk of bias was assessed with Cochrane Risk of Bias 2. Data on systolic and diastolic blood pressure reduction were synthesised in a meta-analysis, and data on reach, uptake and feasibility were summarised narratively. Grading of Recommendations, Assessment, Development, and Evaluation criteria were used to evaluate the level of evidence. The study was registered with PROSPERO CRD42021247845. FINDINGS Of the 3235 records identified, 29 RCTs from 13 regions (n=7592 participants) were included in the systematic review, and 28 of these RCTs (n=7092 participants) were included in the meta-analysis. 11 studies used SMS as the primary mode of delivery of the digital health intervention, 13 used smartphone applications, and five used websites. Overall, digital health intervention group participants had a -3·62 mm Hg (95% CI -5·22 to -2·02) greater reduction in systolic blood pressure, and a -2·45 mm Hg (-3·83 to -1·07) greater reduction in diastolic blood pressure, compared with control group participants. No statistically significant differences between the three different modes of delivery were observed for both the systolic (p=0·73) and the diastolic blood pressure (p=0·80) outcomes. Smartphone application interventions had a statistically significant reduction in diastolic blood pressure (-2·45 mm Hg [-4·15 to -0·74]); however, there were no statistically significant reductions for SMS interventions (-1·80 mm Hg [-4·60 to 1·00]) or website interventions (-3·43 mm Hg [-7·24 to 0·38]). Due to the considerable heterogeneity between included studies and the high risk of bias in some, the level of evidence was assigned a low overall score. Interventions were more effective among people with greater severity of hypertension at baseline. SMS interventions reported higher reach and smartphone application studies reported higher uptake, but differences were not statistically significant. INTERPRETATION SMS, smartphone application, and website interventions were associated with statistically and clinically significant systolic and diastolic blood pressure reductions, compared with usual care, regardless of the mode of delivery of the intervention. This conclusion is tempered by the considerable heterogeneity of included studies and the high risk of bias in most. Future studies need to describe in detail the mediators and moderators of the effectiveness and implementation of these interventions, to both further improve their effectiveness as well as increase their reach, uptake, and feasibility. FUNDING European Union's Horizon 2020 Research and Innovation Programme.
-
6.
Cost effectiveness review of text messaging, smartphone application, and website interventions targeting T2DM or hypertension.
Willems, R, Annemans, L, Siopis, G, Moschonis, G, Vedanthan, R, Jung, J, Kwasnicka, D, Oldenburg, B, d'Antonio, C, Girolami, S, et al
NPJ digital medicine. 2023;(1):150
Abstract
Digital health interventions have been shown to be clinically-effective for type 2 diabetes mellitus (T2DM) and hypertension prevention and treatment. This study synthesizes and compares the cost-effectiveness of text-messaging, smartphone application, and websites by searching CINAHL, Cochrane Central, Embase, Medline and PsycInfo for full economic or cost-minimisation studies of digital health interventions in adults with or at risk of T2DM and/or hypertension. Costs and health effects are synthesised narratively. Study quality appraisal using the Consensus on Health Economic Criteria (CHEC) list results in recommendations for future health economic evaluations of digital health interventions. Of 3056 records identified, 14 studies are included (7 studies applied text-messaging, 4 employed smartphone applications, and 5 used websites). Ten studies are cost-utility analyses: incremental cost-utility ratios (ICUR) vary from dominant to €75,233/quality-adjusted life year (QALY), with a median of €3840/QALY (interquartile range €16,179). One study finds no QALY difference. None of the three digital health intervention modes is associated with substantially better cost-effectiveness. Interventions are consistently cost-effective in populations with (pre)T2DM but not in populations with hypertension. Mean quality score is 63.0% (standard deviation 13.7%). Substandard application of time horizon, sensitivity analysis, and subgroup analysis next to transparency concerns (regarding competing alternatives, perspective, and costing) downgrades quality of evidence. In conclusion, smartphone application, text-messaging, and website-based interventions are cost-effective without substantial differences between the different delivery modes. Future health economic studies should increase transparency, conduct sufficient sensitivity analyses, and appraise the ICUR more critically in light of a reasoned willingness-to-pay threshold.Registration: PROSPERO (CRD42021247845).
-
7.
Long-term cardiometabolic health in people born after assisted reproductive technology: a multi-cohort analysis.
Elhakeem, A, Taylor, AE, Inskip, HM, Huang, JY, Mansell, T, Rodrigues, C, Asta, F, Blaauwendraad, SM, Håberg, SE, Halliday, J, et al
European heart journal. 2023;(16):1464-1473
-
-
Free full text
-
Abstract
AIMS: To examine associations of assisted reproductive technology (ART) conception (vs. natural conception: NC) with offspring cardiometabolic health outcomes and whether these differ with age. METHODS AND RESULTS Differences in systolic (SBP) and diastolic blood pressure (DBP), heart rate (HR), lipids, and hyperglycaemic/insulin resistance markers were examined using multiple linear regression models in 14 population-based birth cohorts in Europe, Australia, and Singapore, and results were combined using meta-analysis. Change in cardiometabolic outcomes from 2 to 26 years was examined using trajectory modelling of four cohorts with repeated measures. 35 938 (654 ART) offspring were included in the meta-analysis. Mean age ranged from 13 months to 27.4 years but was <10 years in 11/14 cohorts. Meta-analysis found no statistical difference (ART minus NC) in SBP (-0.53 mmHg; 95% CI:-1.59 to 0.53), DBP (-0.24 mmHg; -0.83 to 0.35), or HR (0.02 beat/min; -0.91 to 0.94). Total cholesterol (2.59%; 0.10-5.07), HDL cholesterol (4.16%; 2.52-5.81), LDL cholesterol (4.95%; 0.47-9.43) were statistically significantly higher in ART-conceived vs. NC offspring. No statistical difference was seen for triglycerides (TG), glucose, insulin, and glycated haemoglobin. Long-term follow-up of 17 244 (244 ART) births identified statistically significant associations between ART and lower predicted SBP/DBP in childhood, and subtle trajectories to higher SBP and TG in young adulthood; however, most differences were not statistically significant. CONCLUSION These findings of small and statistically non-significant differences in offspring cardiometabolic outcomes should reassure people receiving ART. Longer-term follow-up is warranted to investigate changes over adulthood in the risks of hypertension, dyslipidaemia, and preclinical and clinical cardiovascular disease.
-
8.
Frequency of family meals and food consumption in families at high risk of type 2 diabetes: the Feel4Diabetes-study.
Mahmood, L, González-Gil, EM, Schwarz, P, Herrmann, S, Karaglani, E, Cardon, G, De Vylder, F, Willems, R, Makrilakis, K, Liatis, S, et al
European journal of pediatrics. 2022;(6):2523-2534
-
-
Free full text
-
Abstract
UNLABELLED A family meal is defined as a meal consumed together by the members of a family or by having ≥ 1 parent present during a meal. The frequency of family meals has been associated with healthier food intake patterns in both children and parents. This study aimed to investigate in families at high risk for developing type 2 diabetes across Europe the association (i) between family meals' frequency and food consumption and diet quality among parents and (ii) between family meals' frequency and children's food consumption. Moreover, the study aimed to elucidate the mediating effect of parental diet quality on the association between family meals' frequency and children's food consumption. Food consumption frequency and anthropometric were collected cross-sectionally from a representative sample of 1964 families from the European Feel4Diabetes-study. Regression and mediation analyses were applied by gender of children. Positive and significant associations were found between the frequency of family meals and parental food consumption (β = 0.84; 95% CI 0.57, 1.45) and diet quality (β = 0.30; 95% CI 0.19, 0.42). For children, more frequent family meals were significantly associated with healthier food consumption (boys, β = 0.172, p < 0.05; girls, β = 0.114, p < 0.01). A partial mediation effect of the parental diet quality was shown on the association between the frequency of family meals and the consumption of some selected food items (i.e., milk products and salty snacks) among boys and girls. The strongest mediation effect of parental diet quality was found on the association between the frequency of family breakfast and the consumption of salty snacks and milk and milk products (62.5% and 37.5%, respectively) among girls. CONCLUSIONS The frequency of family meals is positively associated with improved food consumption patterns (i.e., higher intake of fruits and vegetables and reduced consumption of sweets) in both parents and children. However, the association in children is partially mediated by parents' diet quality. The promotion of consuming meals together in the family could be a potentially effective strategy for interventions aiming to establish and maintain healthy food consumption patterns among children. TRIAL REGISTRATION The Feel4Diabetes-study is registered with the clinical trials registry (NCT02393872), http://clinicaltrials.gov , March 20, 2015. WHAT IS KNOWN • Parents' eating habits and diet quality play an important role in shaping dietary patterns in children • Family meals frequency is associated with improved diet quality of children in healthy population What is New: • Frequency of family meals was significantly associated with healthier food consumption among parents and children in families at high risk of type 2 diabetes in six European countries. • Parental diet quality mediates the association between family meals frequency and the consumption of some selected food items among children.
-
9.
Developing a risk assessment tool for identifying individuals at high risk for developing insulin resistance in European adolescents: the HELENA-IR score.
Kondakis, K, Grammatikaki, E, Kondakis, M, Molnar, D, Gómez-Martínez, S, González-Gross, M, Kafatos, A, Manios, Y, Pavón, DJ, Gottrand, F, et al
Journal of pediatric endocrinology & metabolism : JPEM. 2022;(12):1518-1527
Abstract
OBJECTIVES To develop and validate an easy-to-use screening tool for identifying adolescents at high-risk for insulin resistance (IR). METHODS Α total of 1,053 adolescents (554 females), aged 12.5 to 17.5 years with complete data on glucose and insulin levels were included. Body mass index (BMI), fat mass index (FMI) and the homeostasis model assessment for insulin resistance (HOMA-IR) were calculated. VO2max was predicted using 20 m multi-stage fitness test. The population was randomly separated into two cohorts for the development (n=702) and validation (n=351) of the index, respectively. Factors associated with high HOMA-IR were identified by Spearman correlation in the development cohort; multiple logistic regression was performed for all identified independent factors to develop a score index. Finally, receiver operating characteristic (ROC) analysis was performed in the validation cohort and was used to define the cut-off values that could identify adolescents above the 75th and the 95th percentile for HOMA-IR. RESULTS BMI and VO2max significantly identified high HOMA-IR in males; and FMI, TV watching and VO2max in females. The HELENA-IR index scores range from 0 to 29 for males and 0 to 43 for females. The Area Under the Curve, sensitivity and specificity for identifying males above the 75th and 95th of HOMA-IR percentiles were 0.635 (95%CI: 0.542-0.725), 0.513 and 0.735, and 0.714 (95%CI: 0.499-0.728), 0.625 and 0.905, respectively. For females, the corresponding values were 0.632 (95%CI: 0.538-0.725), 0.568 and 0.652, and 0.708 (95%CI: 0.559-0.725), 0.667 and 0.617, respectively. Simple algorithms were created using the index cut-off scores. CONCLUSIONS Paediatricians or physical education teachers can use easy-to-obtain and non-invasive measures to apply the HELENA-IR score and identify adolescents at high risk for IR, who should be referred for further tests.
-
10.
Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project.
Kjølbæk, L, Manios, Y, Blaak, EE, Martínez, JA, Feskens, EJM, Finlayson, G, Andersen, SSH, Reppas, K, Navas-Carretero, S, Adam, TC, et al
BMJ open. 2022;(10):e061075
Abstract
INTRODUCTION The aim of this randomised controlled trial (RCT) is to investigate whether prolonged consumption of sweeteners and sweetness enhancers (S&SEs) within a healthy diet will improve weight loss maintenance and obesity-related risk factors and affect safety markers compared with sugar. METHODS AND ANALYSIS SWEET (S&SEs: prolonged effects on health, obesity and safety) is a 1-year multicentre RCT including at least 330 adults with overweight (18-65 years, body mass index (BMI) >25 kg/m2) and 40 children (6-12 years, BMI-for-age >85th percentile). In an initial 2-month period, adults will consume a low-energy diet with the aim to achieve ≥5% weight loss. Children are advised to consume a generally healthy diet to maintain body weight, thus reducing their BMI-for-age z-score. In the following 10 months, participants will be randomised to follow a healthy ad libitum diet with or without S&SE products. Clinical investigations are scheduled at baseline, after 2, 6 and 12 months. The primary outcomes are body weight for efficacy and gut microbiota composition (in relation to metabolic health) for safety, both in adults. Secondary outcomes include anthropometry, risk markers for type-2 diabetes and cardiovascular diseases, questionnaires including, for example, food preferences, craving and appetite and tests for allergenicity. ETHICS AND DISSEMINATION The trial protocol has been approved by the following national ethical committees; The research ethics committees of the capital region (Denmark), approval code: H-19040679, The medical ethics committee of the University Hospital Maastricht and Maastricht University (the Netherlands), approval code: NL70977.068.19/METC19-056s, Research Ethics Committee of the University of Navarra (Spain), approval code: 2019.146 mod1, Research Ethics Committee of Harokopio University (Greece), approval code: 1810/18-06-2019. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be published in international peer-reviewed scientific journals regardless of whether the findings are positive, negative or inconclusive. TRIAL REGISTRATION NUMBER NCT04226911 (Clinicaltrials.gov).